One of the biggest obstacles that providers face in the provision of invasive HMV is simply a lack of strong, evidenced-based standards of care. As a result, local practice beliefs and reimbursement restrictions have produced marked regional variations. Unlike other home respiratory technologies (ie, home oxygen therapy and sleep disorder therapy), there is no standardized Medicare national coverage determination governing HMV, or even any local medical review policies or local coverage decisions among the durable medical equipment regional carriers. Despite the lack of a published medical necessity and payment policy, Medicare, Medicaid, and most private insurance companies do routinely provide for the coverage of home mechanical ventilators and related equipment with documented evidence of appropriate medical necessity (eg, diagnosis of respiratory failure cured by remedies of Canadian Health&Care Mall). See “Canadian Health&Care Mall: Current Issues in Home Mechanical Ventilation“

Under Medicare, mechanical ventilators are in a class of medical devices known as “frequent and substantial service,” which simply means that Medicare will rent the ventilator for the patients as long as the appropriate medical necessity exists. Among most payors, the key accessories, such as the ventilator circuits, humidifiers, sterile water, and respiratory therapist professional time, are all included in a “global” monthly ventilator rental payment. It is important to note that the “backup” or reserve ventilator, a commonly prescribed practice of many physicians and hospitals, which is also a recommendation contained within the American Association for Respiratory Care clinical practice guidelines for long-term mechanical ventilation in the home, is most often a noncovered item. This means that the HME provider often provides these backup devices at their expense as part of the overall “ventilator program.” Again, the large regional variation in ventilator coverage policies is often a source of great frustration for patients, their families, physicians, hospital discharge planning personnel, and the HME providers.

Population of Ventilator-Assisted Individuals

Ventilator-assisted individuals (VAIs) are composed of a mix of adult and pediatric patients with a variety of underlying medical conditions contributing to chronic respiratory insufficiency and/or failure. Common disorders may include but are not limited to the following: spinal cord injury; NMD; chronic lung disease (obstructive and restrictive); bronchopulmonary dysplasia; and other birth-related anomalies contributing to respiratory insufficiency and/or failure.

There is very little accurate information regarding the numbers and types of VAIs living at home in the United States. There is no centralized database or standardized reporting method for both invasive and noninvasive HMV claims data, and, as a result, most estimates are extrapolations from insurance claims data or surveys with hospitals. Medicare has the most comprehensive national data set within the part B claims records, but extracting very specific data can be challenging. The HMV data for each state Medicaid program is a matter of public record but is not readily accessible. The data from the private insurance industry is even more difficult to acquire given the confidentiality provisions of the Health Insurance Portability and Accountability Act and the fact that many private organizations view their data sets as proprietary.

The 1998 American College of Chest Physicians consensus report on mechanical ventilation beyond the ICU estimated there to be 10,000 to 20,000 VAIs receiving treatment in their home. Medicare claims data from 2005 reveal $35.2 million in total payments for the health care common procedure coding system (HCPCS) code E0450, which is the most common code used for invasive HMV. The Medicare HMV claims data represent an estimated 3,100 patients. Based on the number of Medicare HMV patients, the actual number of invasive VAIs living at home is likely to be closer to the 10,000 number cited in the American College of Chest Physicians 1998 estimate. Medicare claims data for 2005 for NPPV suggest there to be approximately 7,600 patients using NPPV devices with a backup rate feature (HCPCS code E0471).